Hearing and Vestibular Disorders Clinical Trial
Official title:
The Use of the PoNS™ Device in the Treatment of Blunt and Blast Induced Vestibular Disorders
Traumatic brain injury (TBI) is a major worldwide health issue. Figures from the Centers for Disease control show that 1.7 million people suffer a TBI annually. Meanwhile the World Health Organization recognizes TBI as one of the most significant health issues in developing countries. In the military, mild traumatic brain injury (mTBI) is one of the most frequent sequela of modern war. Dizziness and balance disorders are the most frequent sequela of mTBI and account for a significant degree of mTBI morbidity. At the current time, the best treatment modality for dizziness secondary to mTBI is vestibular rehabilitation (VR). While VR is effective, the therapy is time consuming, not universally successful, and results in incomplete recovery by many patients. Work needs to be done in an attempt to improve therapy outcomes. This project will study the use of neuromodulation (through stimulation of the tongue) as an adjuvant to improve the effectiveness of VR and reduce the time involved in VR. Given past work with variants on this minimal medical impact appliance, using the PoNS™ device to augment therapy may result in a significant improvement in VR outcomes. Given the enormous public health and military burden of mTBI, and given that dizziness is a major component often responsible for significant morbidity, this project has significant military and civilian impact and can be beneficial to those who suffer mTBI worldwide.
The CN-NINM intervention is an experimental regimen. It has been developed over the last 12
years at Tactile Communication and Neurorehabilitation Laboratory (TCNL) at the University of
Wisconsin - Madison. All human subjects testing was performed under IRB approval. The PoNS™
is an experimental device that has been evolved over this same period at TCNL, and is not FDA
approved. An Investigator's Brochure and attendant Safety Chart have been developed to
satisfy requirements for an Investigational Device Exemption, and provide additional context
with respect to the research proposed here.
The goal of this work is to test the effectiveness of this device with standard
rehabilitation therapy on individuals who have operationally induced balance disorders from
blunt or blast head trauma.
SPECIFIC OBJECTIVES:
1. To compare the effectiveness of active PoNS-2 (PoNS™) device combined with standard
vestibular rehabilitation to a placebo PoNS™ device with vestibular rehabilitation in
patients with blast and blunt head trauma induced dizziness over the time period of a
standard course of therapy.
2. To compare the effectiveness of active PoNS™ device combined with standard vestibular
rehabilitation to a placebo PoNS™ device with vestibular rehabilitation in patients with
blast and blunt head trauma induced dizziness three months after a standard course of
rehabilitation.
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